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Clinical Trials/NCT02877368
NCT02877368
Completed
Not Applicable

Sarcopenia in Patients With Gastrointestinal Stromal Tumours

CHU de Reims1 site in 1 country31 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Stromal Tumours
Sponsor
CHU de Reims
Enrollment
31
Locations
1
Primary Endpoint
sarcopenia
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The treatment of advanced gastrointestinal stromal tumours (GIST) has shifted since the arrival of targeted therapies. Imatinib is an active multikinase inhibitor that mainly targets C-kit tyrosine-kinase receptors and the platelet-derived growth factor receptor. Imatinib use has been validated for adjuvant and palliative therapy settings. Imatinib is generally well-tolerated and known to improve performance status but up to 16% grades 3-4 toxicities, leading to at least 40% withdrawals, have been reported.

Recently, in oncology, sarcopenia was shown to be a predictor of severe toxicity patients included in phase 1 trials, suggesting that it should be considered an inclusion criterion for such studies. Sarcopenic patients had low performance status, shorter survival, more chemotherapy toxicities and post-operative infections, and longer post-operative hospitalization times. In addition, exposure to tyrosine-kinase inhibitors (e.g. sorafenib or sunitinib) has been associated with dose-limiting toxicity (DLT) in patients with renal cell or hepatocellular carcinomas.

Computed tomography (CT) scans acquired during routine care have been validated as an accurate and robust imaging technique to evaluate sarcopenia in cancer patients.

Detailed Description

Aims of the study were: * to assess the influence of imatinib on sarcopenia patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) * to compare imatinib-induced toxicities between patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) with pre-treatment sarcopenia and patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST) without pre-treatment sarcopenia

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
October 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with advanced or high-risk resected gastrointestinal stromal tumours (GIST)
  • Patients treated with imatinib prescribed at a fixed dose of 400 mg/day from 1 January 2005 to 31 December 2013
  • Aged \> 18 years

Exclusion Criteria

  • Patients who did not have CT imaging within the 30 days preceding treatment onset

Outcomes

Primary Outcomes

sarcopenia

Time Frame: Day 0

Sarcopenia was defined for men by lumbar skeletal muscle index \<53 cm2/m2 with body mass index \>25 kg/m2 and \<43 cm2/m2 with body mass index \<25 kg/m2 Sarcopenia was defined for women, by lumbar skeletal muscle index \<41 cm2/m2 with any body mass index.

Secondary Outcomes

  • Imatinib-induced toxicities(Month 3)

Study Sites (1)

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